Sterile products manufacture represents the most hazardous activity (to the patient!) performed by pharmaceutical companies.

This is why it attracts so much regulatory scrutiny!

Recent regulations and guidelines from EU (Annex 1) and FDA ‘Sterile Drug Products Produced by Aseptic Processing’ are confusing to many and very difficult – and expensive – to comply with in full.

This course is designed to help you comply with these and other documents in a way that is…

Practical

Scientifically sound

Cost-effective

This is by far the most popular of our courses – hundreds of people attend it every year, either through this residential course or via courses run in their companies – and delegate feedback is excellent!

What You Will Learn

Current EU and FDA requirements for…

design and qualification of cleanrooms

environmental standards for controlled environments

control of key utilities

sterilisation processes

process simulations (media fills)

inspection and integrity testing

How to satisfy these expectations in a practical way

How to identify the root cause of any problem… and make the right risk-based decision!

The influence of FDA’s ‘PAT’ initiative on aseptic processing

Course Outline

Current Standards and Regulatory Requirements

ISO 14644

EU GMP Guide Annex 1

FDA Guideline ‘Sterile Drug Products Produced by Aseptic Processing’

The Cleanroom

Design

Qualification

HVAC systems and HEPA filter selection

Alternatives to Conventional Cleanrooms

Isolator technology

Critical Utilities

Steam – generation and quality expectations

Water – generation, storage and control

Sterilisation Processes

EU and US expectations for…

steam sterilisation

dry heat sterilisation

filtration

Other sterilisation processes

ethylene oxide

irradiation

vaporised hydrogen peroxide

Environmental Monitoring

Monitoring techniques

Designing an effective monitoring programme

Setting alert and action levels

Data management

Process Simulations (Media Fills)

Understanding the strengths and weaknesses of the media fill

Current regulatory expectations

How to demonstrate compliance

Disinfection Practices

The importance of TACT

Selection of disinfectants

Validation of disinfection procedures

Container Integrity Testing and Particulate Inspection

Methodologies

Strengths and weaknesses

Regulatory expectations

People Issues

Gowning and gowning practices

Qualification of cleanroom operators

Good aseptic practices

Problem Solving and Troubleshooting Tools and Techniques

Course Tutors

John Johnson

Darren Jones

The start and finish times given are approximate, please contact our office for further information.

Contact Details

Payment Instructions

By Bank Transfer — We are happy to accept payment directly into our bank account so long as:

the full amount of the invoice is received net of all local and UK bank charges within 30 days from date of invoice

the payment timescale quoted at the bottom of our invoices is strictly adhered to

a remittance slip giving clear details of our invoice number is received at this office to coincide with the payment being credited to our bank account

Our bank details will be sent with the invoice.

By Cheque — Payment should be made by sterling cheque drawn on a UK bank and payable to NSF Health Sciences Ltd. Please ensure that the full invoiced amount, net of all local and UK bank charges, is received within 30 days from date of invoice.

Please note that, in both cases, if any bank charges are deducted prior to receipt, this amount will be re-invoiced to yourselves.

By Credit or Debit Card — Using Regonline Secure Payment facility.

Payments — A VAT invoice (if applicable) will be provided (VAT Reg No. GB 927 3679 85). Settlement must be received at least 10 working days prior to the course start date. Cancellations within 25 working days of the course start date are subject to charges (see Cancellations section below). If a Purchase Order number is necessary to effect settlement of our invoice, please provide.

Cancellations — Written cancellations with a full refund will be accepted up to 25 working days before the start date of the course. A fee of 50% will be payable for cancellations received between 10 and 25 working days before the start of the course. Full course fees will be charged for cancellations received within 10 working days of the course start date. Delegate substitutions may be made at any time up to the start of the course. Refunds will be made within 30 days of receiving the written cancellation by the same method that payment was made.

Late Payment Clause

We understand and will exercise our statutory right to claim interest at 2.5% above the prevailing Bank of England base rate under the Late Payment of Commercial Debts (Interest) Act 1998 if we are not paid according to our agreed credit terms.

The programme and other information contained on this website are correct at the time of publishing and are published in good faith. We reserve the right to make any changes which may become necessary.